Medivir Ab · OMXSTO:MVIR
Medivir Ab — H.C. Wainwright BioConnect 2021 Conference
27 slides from Medivir Ab's conference presentation, January 2021
Slide 1: H.C. Wainwright BioConnect 2021 Conference
H.C. WAINWRIGHT BIOCONNECT 2021 CONFERENCE VIRTUAL JANUARY, 2021
Slide 2: Important notice
Important notice You must read the following before continuing. The following applies to this document and the information provided in this presentation by Medivir AB (publ) (the “Company”) or any person on behalf of the Company and any other material distributed or statements made in connection wit
Slide 3: Table of content
Table of content Slide 3
Slide 4: Table of content
Table of content 1. Executive summary 2. MIV-818 o Mode of action and preclinical data o Clinical development o Potential indications 3. Other assets 4. Milestones and summary Slide 4
Slide 5: Executive summary
Executive summary Proprietary clinical asset • MIV-818 – A liver directed nucleotide prodrug Founded: 1988 • In phase Ib clinical development Listed: Nasdaq OMX • Opportunities for breakthrough oncology indications Location: Stockholm Cash position: c. SEK 83M1) The company Market Cap: SEK 200M2) •
Slide 6: Focused clinical program
Focused clinical program Nucleotide prodrug Indication Research Preclinical Phase I Exclusivity MIV-818 Liver cancer IP : 2035 Multiple programs for partnering/out-licensing Compound Mechanism Indication Phase I Phase II Phase III Exclusivity Remetinostat Topical HDAC MF-CTCL1) IP : 2034 BCC Birinap
Slide 7: MIV-818 Mode of action and preclinical data
MIV-818 Mode of action and preclinical data Slide 7
Slide 8: MIV-818: A liver-directed nucleotide
MIV-818: A liver-directed nucleotide • MIV-818 is an oral prodrug • Once absorbed from the GI-tract, MIV-818 is transported to the liver • The prodrug is taken up by liver cancer cells and converted into troxacitabine triphosphate (TRX-TP) • TRX-TP is incorporated into DNA and causes double-strand D
Slide 9: Troxacitabine - Background
Troxacitabine - Background • Developed by Shire Biochem Inc. and SGX pharmaceuticals • Nucleoside analogue with anticancer activity • Administration route, intravenous injection • More than 700 patients have received the drug in phase I/II/III trials • In a 48 patient phase I/II trial in AML, 5 pati
Slide 10: Preclinical evidence for MIV-818 liver targeting
Preclinical evidence for MIV-818 liver targeting Compound Route Dose Liver TRX-TP/Plasma (µmol/kg) TRX (AUC ratio) Troxacitabine (TRX) iv 80 <0.016 MIV-818 oral 80 1.9 • MIV-818 exhibited substantial liver targeting by preferential formation of the active TRX-TP metabolite in liver of rats • MIV-818
Slide 11: MIV-818 shows efficacy in preclinical HCC models
MIV-818 shows efficacy in preclinical HCC models Inhibition of tumor growth in mouse HCC Inhibition of patient-derived HCC cell lines in vitro xenograft models in vivo In h ib itio n o f P D C s ( n = 1 5 ) M IV - 8 1 8 d o s e -r e s p o n s e in H e p G 2 m o d e l 100 D o s in g (p o B ID x 5 d )
Slide 12: MIV-818: enhanced anti-tumor effect in combination with MKI
MIV-818: enhanced anti-tumor effect in combination with MKI in preclinical HCC models C o m b in a t io n w it h M IV - 8 1 8 a n d s o r a fe n ib (N = 8 ) C o m b in a t io n o f M IV - 8 1 8 a n d L e n v a t in ib (N = 1 0 ) D o s in g p e rio d D o s in g p e rio d 1600 1600 V e h ic le V e h i
Slide 13: Summary
Summary • Preclinical evidence of increased liver targeting with MIV-818 vs i.v. troxacitabine • MIV-818 has demonstrated efficacy in multiple preclinical HCC models • Significantly better tumor inhibition vs. MKIs in HepG2 xenograft mouse model • Predictive dose response • Evidence of activity in h
Slide 14: MIV-818 Clinical development
MIV-818 Clinical development Slide 14
Slide 15: MIV-818: Phase Ia objectives
MIV-818: Phase Ia objectives Primary objectives • To assess safety and tolerability of escalating doses of MIV-818 in patients with hepatocellular carcinoma (HCC), Intra hepatic cholangiocarcinoma (iCCA), or metastatic liver disease and to establish the phase Ib start dose Key secondary and explorat
Slide 16: MIV-818: Selective effect signal in liver cancer in phase Ia
MIV-818: Selective effect signal in liver cancer in phase Ia • Clear signs of cell death, measured as DNA damage, observed in liver biopsies from tumor tissue in MIV-818 treated patients • The tumor selective effect is an early proof-of-concept of the intended liver-directed effect in patients Pre-d
Slide 17: MIV-818: Conclusions from phase Ia
MIV-818: Conclusions from phase Ia • Adverse events were generally mild and the few severe adverse events were reversible • Only low levels of MIV-818 and acceptable exposure to troxacitabine were observed in blood after two treatment cycles • Liver biopsies showed selective DNA damage in tumor tiss
Slide 18: MIV-818: Clinical development plan in advanced liver cancer
MIV-818: Clinical development plan in advanced liver cancer Phase Ib -Part A Phase Ib - Part B Phase Ib monotherapy Phase Ib add-on to SoC (n=up to 30) (n=up to 30) Next phase add-on to SoC Interpatient dose escalation Interpatient dose escalation Example: MIV-818 + SoC vs. Placebo + SoC 3+3 design
Slide 19: The liver cancer therapeutics market
The liver cancer therapeutics market Slide 19
Slide 20: Global market for HCC and Colorectal cancer
Global market for HCC and Colorectal cancer HCC Sales Forecast ($m) Colorectal Cancer Sales Forecast ($m) 3 500 12 000 3 000 10 000 2 500 8 000 2 000 ($m) ($m) 6 000 1 500 4 000 1 000 2 000 500 0 0 2018 2025 2018 2025 US EU5 JP China US EU5 Japan China • HCC sales in 8 major markets are estimated to
Slide 21: Other assets
o 3 ssets > . 9 a “3? ee “Other a
Slide 22: Multiple programs for partnering/out-licensing
Multiple programs for partnering/out-licensing Compound Mechanism Indication Phase I Phase II Phase III Exclusivity Remetinostat Topical HDAC MF-CTCL1) IP : 2034 BCC Birinapant SMAC mimetic HNSCC2) IP : 2034 MIV-711 Cathepsin K OA3) IP : 2034 inhibitor 1) Indications: basal cell carcinoma, squamous
Slide 23: Partnering deals executed in 2020
Partnering deals executed in 2020 • Preclinical research deal with Tango Therapeutics • Entered into a license agreement for Chinese rights with Yuanmai Biotech with our product Xerclear® for labial herpes • Option agreement with a biotech company for an undisclosed preclinical research project • Th
Slide 24: Executive summary
Executive summary Proprietary clinical asset • MIV-818 – A liver directed nucleotide prodrug Founded: 1988 • In phase Ib clinical development Listed: Nasdaq OMX • Opportunities for breakthrough oncology indications Location: Stockholm Cash position: c. SEK 83M1) The company Market Cap: SEK 200M2) •
Slide 25: Board of Directors
Board of Directors Chairperson of the Board. Member of the Board since 2015. Member of the Board since 2017. Education: B.Sc. in Economics and Business Administration from the Education: Professor of Tumor Biology at Uppsala University, Stockholm School of Economics. Faculty of Medicine, since 1986.
Slide 26: Key management members
Key management members Chief Financial Officer President and CEO Education: B.Sc. in Economics and Business Administration. Education: Ph.D. Medical Sciences, Karolinska Institutet. Employed: 2019 Employed: 2020 Background: Twenty years of experience in business and finance. Previously Background: F
Slide 27: Shareholder list
Shareholder list De stérsta aktiedgarna 2020-09-30 Innehav Réster i % FORSAKRINGSAKTIEBOLAGET, AVANZA PENSION 2 106 685 867% Nordea Investment Funds 1999 459 8.23% NORDEA LIVFORSAKRING SVERIGE AB 1016 037 418% CREDIT SUISSE (LUXEMBOURG) S.A 668 675 2.75% ALANDSBANKEN | AGARES STALLE 584 062 2.40% NO